In response to CMS’ recently proposed Medicare Part B drug demonstration, dozens of individual patients and patient advocacy groups have mobilized to voice their concerns with the model’s use of "comparative effectiveness" research and "cost-effectiveness" data to make coverage decisions. Indeed, patients have expressed a wide range of concerns – from the reliance on assessments such as those generated by the Institute for Clinical and Economic Review (ICER), to the lack of patient engagement in the development of the new reimbursement model.
Instead, patients consistently argue that a truly cost-effective system of care would include tools to inform patients and people with disabilities about their treatment options, and their impacts on outcomes that matter to them – because patients and people with disabilities will adhere to treatment protocols when they are actively engaged and are less likely to encounter significant (and expensive) adverse events as a result.
Hon. Tony Coelho
PIPC Chairman, Patient Advocate
PIPC Chairman, Patient Advocate
Instead of taking the views of patients and people with disabilities seriously, the Centers for Medicare and Medicaid Services (CMS) recently proposed to set national policy based on assessments such as those generated by the Institute for Clinical and Economic Review (ICER)… Reliance on average value assessments is not a policy that drives “value for the patient,” as CMS indicates in the proposed rule - it is a policy intended to contain short-term costs by limiting choices for patients. Yet, the result is a less effective and efficient system of care. A truly cost-effective system of care would include tools to inform patients and people with disabilities about their treatment options, and their impacts on outcomes that matter to them.
While using the QALY might be a nice academic exercise, its use becomes discriminatory when it’s used to ration care for particular groups of patients or prioritize spending. Use of the QALY becomes downright life-threatening when it is used to justify arguments that it’s not “worth it” to treat people with cancer using new drugs that have recently come to market, solely based on the expense of these drugs and the assumption that a sick person’s time is worth less.
Marc Boutin
National Health Council
National Health Council
Value assessment, from the patient’s perspective, includes whether the treatment permits the individual to fulfill personal goals, such as a woman with multiple sclerosis to live longer to see a grandchild grow up or a man with Parkinson’s who wants to keep his condition concealed for fear of discrimination at work. The patient community brings to the value discussion perspectives that have been informed by their life experiences, level of expertise about their condition, and many other factors. The only way a value model can be of benefit to patients – the ultimate user of our health care system – is if people with chronic conditions are part of not only the model development process, but the value discussion in its entirety. Such action is particularly important if physicians and payers look to ‘value’ to inform decisions that can affect the treatment options available to a patient.
Robin Tuohy
Myeloma Caregiver
Myeloma Caregiver
Only physicians and patients have the knowledge and right to decide together what treatment and when to use it, is the best treatment. In fact, patients will need access to our entire armamentarium of drugs over the course of this disease. Since there is currently no cure, many patients have numerous remissions and relapses and each time we relapse, the disease is harder to fight. Why not go with the best treatment plan first, when a patient’s body is stronger and better able to fight? I truly fear that while ICER’s report is well intended, the content of its conclusions can quickly be used by policy makers and payers to limit treatment options to patients.
Andrew Sperling
National Alliance on Mental Illness
National Alliance on Mental Illness
“We get stuck in this timeframe of looking at the cost or the value of a single clinical intervention, whether it’s for the average person or the individual patient, and just the cost of that clinical intervention… we should be measuring the cost of this intervention versus taking it away and how much it’s going to cost the system not in the next quarter, not in the next year, but over the next 40 years.”
Amy Barron
Arthritis Advocate
Arthritis Advocate
It’s imperative to take action against proposals such as outlined by the Medicate Part B demo model. Proposals such as this take the focus away from the patient and quality care. The changes will ultimately lead to less accessibility to some of the medications and facilities which have been life saving for patients with diseases such as rheumatoid arthritis, autoimmune disease and cancer. We are at a pivotal crossroad where we are seeing progress in care; we cannot afford to set back the clock with our treatment.
Eleanor Perfetto
National Health Council
National Health Council
I think, in as much as you think about these cost effectiveness analyses as being the meat grinder, it’s what goes into that meat grinder to get what comes out. There’s so many different ingredients that go in, and where the costs come from, where the QALYs come from, where the outcomes come from. All of those individual pieces are all subject to so many limitations that it’s one of the huge issues with these kinds of approaches and these kinds of models.
Cat Davis Ahmed
Familial Hypercholesterolemia Foundation
Familial Hypercholesterolemia Foundation
People are actually being affected right now, today, by the decisions that are being made - being denied potentially life-saving treatments. So a new value framework in the future is great but there is something happening today that we must address now.
Tom Hardy
Myeloma Patient
Myeloma Patient
I am appalled that a draconian cost-benefit efficacy analysis should inform any decisions regarding the ministration of the healing arts. Medicine advances and saves lives as much by art as by science, as much by heart as by numbers, as much by curiosity as by money. As a compassionate, civilized society, we must offer the best medicine we have to the patients who need it most without reservation. This is our legacy to generations to come.
Jonathan Wilcox
Patients Rising
Patients Rising
Consider the value framework ICER recently unveiled for multiple myeloma, a rare form of blood cancer. It estimates that every year of a sick patient’s life is worth as little as 3/5 of a year for a healthy person. It won’t matter what your doctors say or if there’s a drug that could help you — if the formula says it’s too expensive, you’re done. Think for a moment how Stephen Hawking or Magic Johnson would fare in a system that judged their value in this way.
Jan Wyatt
Arthritis Advocate
Arthritis Advocate
So Medicare has always had this lofty Triple Aim: Care, Health and Cost… Nice words, but it doesn’t seem like they are paying attention to their own goals! A recent Medicare rules change will potentially harm my Health, Cost and Care! [N]ew Medicare rules focused on cost control, may affect my ability to receive needed infusions at my physician’s office. These new rules will potentially force many of us to receive any future therapeutic infusions at random healthcare facilities or hospitals that may have no access to my medical history, have limited space and limited appointment scheduling that could interfere with the required timeliness of my therapy. We need Medicare to stop, look and listen to those of us who require complex infusion care. These new rules are too scary and don’t seem to support the government’s own goals!
Brissan Guardado
Association of Community Cancer Centers
Association of Community Cancer Centers
I think, considering the patient’s going through the journey, we should always set them as the focal point. It’s important. You can’t move forward with this without hearing the voice of the patient or even the caregiver or the family members.
Professor John Harris
University of Manchester
University of Manchester
The only way to deal between individuals in a way which treats them as equals when resources are scarce, is to allocate those resources in a way which exhibits no preference. To discriminate between people on the grounds of quality of life, or QALY, or life-expectancy, is as unwarranted as it would be to discriminate on the grounds of race or gender… The QALY and other quality-of-life criteria are, as we have seen, both dangerous and irrelevant as are considerations based on life-expectancy or on 'lifeyears' generated by the proposed treatment. If health professionals are forced by the scarcity of resources to choose, not whether to treat but who to treat, they must avoid any method that amounts to unjust discrimination.
Jeff Stier
National Center for Public Policy Research
National Center for Public Policy Research
ICER, which holds itself out as a kind of Consumer Reports for drugs, is basically an industry-backed comparative effectiveness calculator. That ICER is industry backed isn’t the problem, it’s that it uses comparative effectiveness to lend an air of legitimacy to the formulary shenanigans. Different people respond differently to medications. The blue pills don’t always work the same as the red pills. Individuals, it turns out, are different.
Wayne Winegarden
Pacific Research Institute
Pacific Research Institute
For most markets, a good’s price indicates its value – the concepts are inseparable. But not in the health care sector. In the absence of an effective price system, ICER is attempting to be the NICE of the U.S. and determine which innovations are valuable for patients. This is a herculean task at best, and when coupled with ICER’s unanswered methodological questions, Californians should be wary of basing their families’ health care coverage decisions on ICER’s conclusions.
